Advocacy at a Glance
October 10, 2014
Advocacy at a Glance offers you the bullet point summary of current advocacy issues associated with the goals of the Alliance for a Stronger FDA.
- Alliance Launches Planned Series of Hill “FDA 101” Briefings. On October 17, the Alliance will be holding its first “FDA 101” Congressional briefing. Designed to provide Hill staffers with background on the agency, its unique mission and growing responsibilities, the briefing will include presentations by FDA, the CEO of a small biotech company, a consumer food safety advocate, a representative of a food trade association, and a disease group advocate. We encourage all Alliance members to come to the event and to invite your Hill contacts, as well. The importance of these briefings to the Alliance’s mission was described in an Analysis and Commentary this August.
- Mid-term Elections: What Will Congress Look Like in 2015? This past week, more than 50 Alliance members participated in a pre-election briefing presented by senior staff from Akin Gump. A similar briefing will be held about a week after the election for Alliance members only. Meantime, this week’s Analysis and Commentary is devoted to the question: what election outcomes would be best for FDA?
- How Many Drugs and NME’s Has FDA Approved — Since the Very Beginning? Ever wondered at how many drugs have been approved by FDA and its predecessors since 1827? The number is 1,453, with most approved in more recent years. That and a number of other interesting facts (which company has the most NME’s?) can be found in a recent Drug Discovery Today article that is described in the RAPS Regulatory Focus.
- New Estimate of the Cost of Foodborne Illness, Based on USDA Analysis by Pathogen. Not surprisingly, Salmonella causes the most economic damage ($3.7 billion), but the less well-known Toxoplasma gondii comes in second with $3.3 billion in damages. Other data and links to the USDA worksheets can be found here.
- New FDA Program Alignment Should Produce Better Inspectors and Regulators. This past week, Commissioner Hamburg announced a program realignment within FDA to address new regulatory challenges (new agency missions, globalization, increased scientific complexity) by increasing initiatives in the areas of professional specialization, training, work planning, compliance policy and enforcement strategy, imports, laboratory optimization and information technology.